For Patients

Azulfidine EN-tabs (sulfasalazine delayed release tablets) is used to treat moderate to severe ulcerative colitis. It is also used to treat rheumatoid arthritis in children and adults who have received other arthritis medications without successful treatment of symptoms. Azulfidine is an anti-inflammatory agent and immunomodulatory agent. This medication is available in generic form. Common side effects include stomach upset, nausea, vomiting, loss of appetite, mouth sores, headache, dizziness, or unusual tiredness.

Adult doses of Azulfidine range from 1000 mg to 4000 mg daily, taken 2 to 4 times daily depending on the condition being treated. Pediatric doses are determined by weight. Azulfidine EN-tabs may interact with digoxin, folic acid, or vitamin or mineral supplements that contain folic acid. There may be other drugs that can interact with Azulfidine. Tell your doctor about all the prescription and over-the-counter medications and supplements you use. During pregnancy, Azulfidine EN-tabs should be used only when prescribed. Caution is advised if this medication is used near the expected delivery date because similar drugs may cause harm to a newborn. This medication may lower folic acid levels, increasing the risk of spinal cord defects. Consult your doctor about taking enough folic acid. This drug passes into breast milk and could have undesirable effects on a nursing infant. Consult your doctor before breast-feeding.

Our Azulfidine EN-tabs (sulfasalazine delayed release tablets) Side Effects Drug Center provides a comprehensive view of available drug information on the potential side effects when taking this medication.

This is not a complete list of side effects and others may occur. Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.

What is Patient Information in Detail?

Easy-to-read and understand detailed drug information and pill images for the patient or caregiver from Cerner Multum.

SIDE EFFECTS: Stomach upset, nausea, vomiting, loss of appetite, headache, dizziness, or unusual tiredness may occur. If any of these effects persist or worsen, notify your doctor or pharmacist promptly.

This medication may cause your skin and urine to turn orange-yellow. This effect is harmless and will disappear when the medication is stopped.

Rarely, delayed-release tablets of sulfasalazine may appear whole or only partly dissolved in your stool. If this occurs, tell your doctor immediately so your treatment can be changed.

Remember that your doctor has prescribed this medication because he or she has judged that the benefit to you is greater than the risk of side effects. Many people using this medication do not have serious side effects.

This medication may cause temporary male infertility. This effect is reversible when the medication is stopped.

Tell your doctor right away if you have any serious side effects, including: sun sensitivity, hearing changes (e.g., ringing in the ears), mental/mood changes, painful urination, blood in the urine, change in the amount of urine, new lump/growth in the neck (goiter), numbness/tingling of the hands/feet, signs of low blood sugar (e.g., hunger, cold sweat, blurred vision, weakness, fast heartbeat), swollen glands.

SIDE EFFECTS

The most common adverse reactions associated with sulfasalazine
are anorexia, headache, nausea, vomiting, gastric distress, and apparently
reversible oligospermia. These occur in about one-third of the patients. Less
frequent adverse reactions are skin rash, pruritus, urticaria, fever, Heinz
body anemia, hemolytic anemia, and cyanosis, which may occur at a frequency of
one in every thirty patients or less. Experience suggests that with a daily
dosage of 4 g or more, or total serum sulfapyridine levels above 50 μg/mL,
the incidence of adverse reactions tends to increase.

Although the listing which follows includes a few adverse
reactions which have not been reported with this specific drug, the
pharmacological similarities among the sulfonamides require that each of these
reactions be considered when AZULFIDINE Tablets are administered. Less common
or rare adverse reactions include:

The sulfonamides bear certain chemical similarities to
some goitrogens, diuretics (acetazolamide and the thiazides), and oral
hypoglycemic agents. Goiter production, diuresis and hypoglycemia have occurred
rarely in patients receiving sulfonamides. Cross-sensitivity may exist with
these agents. Rats appear to be especially susceptible to the goitrogenic
effects of sulfonamides and long-term administration has produced thyroid
malignancies in this species.

Postmarketing Reports

The following events have been identified during
post-approval use of products which contain (or are metabolized to) mesalamine
in clinical practice. Because they are reported voluntarily from a population
of unknown size, estimates of frequency cannot be made. These events have been
chosen for inclusion due to a combination of seriousness, frequency of
reporting, or potential causal connection to mesalamine: